Cetirizine (Reactine®)
Information last updated: October 2021
Most pregnancies result in healthy babies, but there are chances of complications and unexpected outcomes. These chances are called baseline risks. In Canada, the baseline risk of major birth defects is 3-5%. This means that 3-5 out of 100 babies born in the general population in Canada will be born with a major birth defect. There are also baseline risks for miscarriages (15-25 out of 100 pregnancies), premature birth and other outcomes. The information provided will summarize if taking this drug is likely to change these risks.
Summary: Approximately 1800 pregnancies with exposure to cetirizine during the first trimester were included in studies that examined rates of birth defects. Based on this, it is not expected that taking cetirizine in pregnancy will increase the risk of babies being born with major birth defects above the baseline risk. As well, the limited available information does not raise concerns for increased rates of other adverse pregnancy outcomes. To see more details please click on the tabs below.
Please consult with your health care provider if you are considering stopping or making any changes to your regular medications.
This information about cetirizine is of a general nature and about medical use and does not replace the medical care and advice of your healthcare provider. For questions on dose, timing, side effects, interactions, etc. please consult your healthcare provider. Additionally, please read the patient insert provided with your medication.
Although participants in the studies referenced below may have used cetirizine in various combinations, the studies usually do not provide detailed information on drug combinations. This makes it challenging to comment on the safety of using this medication in combination with others during pregnancy or lactation.
Cetirizine (Reactine®) is an antihistamine. It is used to treat allergies and chronic urticaria (hives).
Cetirizine is the active metabolite (breakdown product) of hydroxyzine, which is another antihistamine. Findings from hydroxyzine exposed pregnancies can be included in the discussion of cetirizine safety in pregnancy. Therefore, the information provided here is based on exposures to both cetirizine and hydroxyzine.
If the product you are using contains other active ingredients, please check our Exposures A to Z for available information on the ingredient(s).
For more information on allergies while pregnant or nursing please see Seasonal Allergies and Allergic Rhinitis in Pregnancy and Lactation.
Pronunciation
There were approximately 1800 pregnancies with exposure to cetirizine during the first trimester included in studies that examined rates of birth defects. Based on these studies, it is not expected that taking cetirizine in pregnancy will increase the risk of babies being born with major birth defects above the baseline risk.
Last updated Mar 2024
If you are taking medications and you notice any new health concerns or symptoms in your nursing infant, please contact their health care provider. In case of emergency, please go to the emergency room or call 911.
People who are taking a medication or substance while providing their breastmilk to an infant need to know how much of the medication or substance is passing into their milk. One of the commonly used measurements to estimate this is the Relative Infant Dose (RID). The RID is estimated by comparing the dose of drug taken in by the infant through breastmilk to the dose that the nursing parent takes. Most medications with an RID of less than 10% are usually compatible with nursing a healthy infant. The RID does not need to be calculated for each person because most of the time it is expected to be similar to what has been found in research studies. We will provide the RID in the information below, when available.
According to the available information, cetirizine passes into breastmilk in small amounts and is not expected to affect the nursing infant. Based on cetirizine breastmilk concentrations of 34 women taking 10mg of cetirizine daily, the RID is estimated to be less than 2%. The frequency of reported adverse effects was not increased in 31 breastfed infants exposed to cetirizine through breastmilk compared to the general population of breastfed infants.
Although questions have been raised on the impact of antihistamines on lactation, we have not located evidence of cetirizine having an adverse impact.
Medications, if not taken as prescribed, if taken beyond the prescribed amount, or if taken in combination with certain other drugs, may cause harm to you and/or your pregnancy or your nursing child.
If you are using drugs or medications for non-medical reasons or beyond what was recommended by a healthcare practitioner and you are pregnant, providing your breastmilk to an infant, or parenting please click Harm Reduction for additional information. In case of emergency, please go to the emergency room or call 911.
Pregnancy:
Based on approximately 1800 pregnancies with exposure to cetirizine in the first trimester, there does not appear to be an increased risk of major congenital malformations above the baseline risk.
Approximately 200-450 (depending on the outcome examined) pregnancies exposed to cetirizine were included in studies examining other pregnancy outcomes. The limited available data does not suggest an increased risk of miscarriage, stillbirth, prematurity, or low birth weight with use of cetirizine or hydroxyzine (included in some of the studies) in pregnancy. However, more data is needed to confirm that there is no increased risk of these outcomes.
No increase in the rates of neonatal distress at birth (defined in this study as resuscitation or neonatal intensive care unit admission or the presence of meconium) was reported in 33 infants exposed to cetirizine during pregnancy. Although the study was small, cetirizine is not expected to increase the rates of neonatal distress in infants exposed during pregnancy.
Lactation:
Last updated Mar 2024
One of the factors that helps to determine if a medication is compatible with nursing is the Relative Infant Dose (RID). The RID provides an estimate of infant’s exposure to a medication through breastmilk. It is the ratio between the infant’s and the nursing individual’s weight-adjusted doses. The infant weight adjusted dose is estimated based on the concentration of medication in breastmilk, and an assumption of infant daily milk consumption of 150 ml/kg/day. In general, for infants with normal growth and development, most medications with an RID of less than 10% are considered compatible with nursing. The RID does not account for infant’s drug metabolism, clearance, or infant blood levels. Although some variability may exist in the RID, in most cases the estimated RID is adequate for clinical purposes and does not need to be calculated for each individual. We will provide the RID in the information below, when available.
According to the available information, cetirizine passes into breastmilk in small amounts and is not expected to affect the nursing infant. Based on cetirizine breastmilk concentrations of 34 nursing women receiving cetirizine 10mg/day, the RID is estimated to be less than 2%. The rate of adverse effects reported in 31 breastfed infants exposed to cetirizine through breastmilk was similar to breastfed infants in the general population.
Although questions have been raised on the impact of antihistamines on lactation, we have not located evidence of cetirizine having an adverse impact.
Harm Reduction:
If your patient may be using drugs or medications not as indicated during pregnancy, while providing breastmilk to an infant, or parenting please click Harm Reduction for additional information. In case of emergency, please advise them to go to the emergency room or call 911.
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Disclaimer
First Exposure does not offer health care treatment. If you have an urgent question about your pregnancy or your baby’s health, you should contact your health care provider directly. If you don’t have a health care provider and you live in Ontario, you have a variety of health care options. In the case of an emergency, visit a hospital emergency room or call 911.